NCT00874796

Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection

A Phase 2b, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS 9450 in Adults With Chronic Hepatitis C Virus Infection (GS-US-227-0106)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of three treatment groups (80 subjects per treatment group) as follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily. Following randomization, subjects will return within seven business days for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. During the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. Following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	GS-9450	Taken as one capsule by mouth once daily
DRUG	Placebo	Taken as one placebo capsule (matching in appearance to GS-9450 capsules) by mouth once daily

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2009-04-03
• Last updated: 2014-02-04

Locations

73 sites across 6 countries: United States, Canada, Germany, Poland, Puerto Rico, United Kingdom